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Permax when used to treat Parkinson's disease, may increase risk of valvular heart disease.

Investigation Source

Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Investigation Scope

Category Information

Investigation Topic

Increased Risk of Bodily Injury

Product or Service

Permax

Injury Types

Death

Primary Pulmonary Hypertension

Congestive Heart Failure

Valve Regurgitation

Valvular Heart Disease

Investigation Details

Permax is in the same class of prescription medications called "ergot-derived receptor dopamine agonists" used in the treatment of Parkinson's disease and other neurological problems such as restless leg syndrome (RLS). Two studies published by the New England Journal of Medicine in January 2007 indicated a statistically significant percentage of those who used Dostinex or Permax developed the potentially serious complication of valvular heart disease. Specifically, there was a significant increased risk of users having mitral, tricuspid, and aortic regurgitation, which could result in congestive heart failure and/or valvular heart disease. Valve regurgitation is a condition in which valves don't close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

In March 2007, the FDA announced a voluntary withdrawal of Permax products as a result of the link to a risk of serious damage to patients' heart valves. According to the release, the products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. In addition to the announcement, the FDA issued a Public Health Advisory detailing the removal of pergolide products from the market. Dostinex (cabergoline) is not approved in the U.S. for treatment of Parkinson's Disease, so the drug remains on the market. The FDA says it is used in a significantly lower dose for the treatment of hyperprolactinemic disorders. The FDA feels there is little chance of heart problems with Dostinex at this dosage, which is why it has not been withdrawn. Valvular heart disease is typically diagnosed by a painless and non-invasive test called an echocardiogram that uses sound waves to determine if the valves of the heart are functioning properly. In many cases, valvular heart disease does not immediately result in symptoms, so if you have taken either of these drugs, we would suggest that you speak to your physicians about having such a test, and about the nature of the risks associated with these two drugs.

At this point in time, it appears that the only Parkinson's related drugs with a demonstrated association with valvular heart disease are Permax and Dostinex. The safer alternative to using these drugs are "non-ergot-derived dopamine receptor agonists". Permax and Dostinex are chemically related to the diet drug "Fen-phen", which was also related to the development of valvular heart disease and another very rare condition call Primary Pulmonary Hypertension (PPH).

Do you have a Permax or Dostinex claim? If you or a loved one has suffered a serious heart injury involving valve damage or death as a result of Permax (pergolide) and/or Dostinex (cabergoline), you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Do not change medications without first consulting your doctor.

Defendant Details

Name (Stock Symbol)

Brief Description

Valeant Pharmaceuticals International (VRX)

Valeant Pharmaceuticals International is a pharmaceutical company that develops and markets specialty pharmaceutical, branded generic and Over The Counter products.

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